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  1. 1
    Peer Reviewed

    Indian National Code for Protection and Promotion of Breast-feeding. [Resolution No. 18-11/81-NT dated 19 Dec 1983].

    India. Ministry of Social Welfare

    Indian Pediatrics. 1984 Mar; 21(3):259-64.

    The objective of the Indian National Code for Protection and Promotion of Breastfeeding is to contribute to the provision of safe and adequate nutrition for infants by the protection and promotion of breastfeeding and by ensuring the proper use of breast milk substitutes, when these are necessary, on the basis of adequate information and through appropriate marketing and distribution. The Code applies to the marketing and practices related thereto, of the following products: breast milk substitutes, including infant formula; other milk products, foods, and beverages, including bottle fed complementary foods, when marketed or otherwise represented to be suitable, with or without modification, for use as a partial or total replacement of breast milk; and feeding bottles and teats. It also applies to their quality and availability and to information about their use. Article 4 of the Code maintains that the government shall ensure that objective and consistent information is provided on infant and young child feeding for use by families and those involved in the field of infant and young child nutrition. This responsibility shall cover the planning, provision, design, and dissemination of information and their control. Informational and educational materials, whether, audio, or visual, should include clear information on the following: the benefits and superiority of breastfeeding; maternal nutrition and preparation for the maintenance of breastfeeding; the negative effect on breastfeeding of introducing partial bottle feeding; the difficulty of reversing the decision not to breastfeed; and where needed, the proper use of infant formula. According to the Code, there shall be no advertising or other form of promotion to the general public of products within the scope of the Code. Manufacturers and distributors should not provide, directly or indirectly, to anybody, samples of products within the scope of this Code. Other provisions of the Code include: health authorities should take appropriate measures to encourage and protect breastfeeding and promote the principles of the Code; health workers should encourage and protect breastfeeding; in systems of sales incentives for marketing personnel, the volume of sales of products within the scope of this Code should not be included in the calculation of bonuses, nor should quotas be set specifically for sales of these products; labels should be designed to provide the necessary information about the appropriate use of the product so as not to discourage breastfeeding; the quality of products is an essential element for the protection of the health of infants and should be of a high recognized standard; and the government shall give effect to the principles and objective of the Code through legislation and other appropriate measures.
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  2. 2

    Oral rehydration salts: an analysis of AID's options.

    Elliott V

    [Columbia Maryland], Westinghouse Electric Corporation, Public Applied Systems, 1984 Sep. 26, [13] p. (Contract No. PDC-1406-I-02-4062-00, W.0.2; Project No. 936-5939-12)

    Westinghouse Health Systems, under a US Agency for International Development (USAID) contract, ass ssed the global supply and demand of oral rehydration salts (ORS) and developed a set of recommendations concerning USAID's future role as a supplier of ORS. 1.5 billion ORS packets (assuming each packet is equivalent to 1 liter of ORS solution) would be required to treat all ORS treatable cases of diarrhea which occur annually among the world's children under 5 years of age. Currently, about 200 million packets are manufactured/year. In 1983, international sources supplied slightly less than 37 million packets, and the remaining packets were produced by local or in-country manufacturers. UN Children's Fund (UNICEF), which currently provides 81% of the international supply, contracts with private firms to manufacture ORS and then distributes the packets to developing countries, either at cost or free of charge. UNICEF purchases the packets for about US$.04-US$.05. USAID provides about 12.3% of the international supply. Prior to 1981, USAID distributed UNICEF packets. Since 1981, USAID has distributed ORS packets manufactured by the US firm of Jianas Brothers. USAID must pay a relatively high price for the packets (US$.08-US$.09) since the manufacturer is required to produce the packets on an as needed basis. Other international suppliers of ORS include the International Dispensary Association, the Swedish International Development Authority, the International Red Cross, and the World Health Organization. Currently, 38 developing countries manufacture and distrubute their own ORS products. These findings indicate that there is a need to increase the supply of ORS; however, the supply and demand in the future is unpredictable. Factors which may alter the supply and demand in the future include 1) the development of superior alternative formulations and different type of ORS products, 2) a reduction in the incidence of diarrhea due to improved environmental conditions or the development of a vaccine for diarrhea, 3) increased production of ORS in developing countries, 4) increased commercial sector involvement in the production and sale of ORS products, and 5) the use of more effective marketing techniques and more efficient distribution systems for ORS products. USAID options as a future supplier of ORS include 1) purchasing and distributing UNICEF packets; 2) contracting with a US firm to develop a central procurement system, similar to USAID's current contraceptive procurement system; 3) contracting with the a US firm to establish a ORS stockpile of a specified amount; 4) promoting private and public sector production of ORS within developing countries; 5) including ORS as 1 of the commodities available to all USAID assisted countries. The investigators recommended that USAID should contribute toward increasing the global supply of ORS; however, given the unpredictability of the ORS demand and supply, USAID should adopt a short-term and flexible strategy. This strategy precludes the establishment of a central procurement system; instead, USAID should contract a private firm to establish an ORS stockpile and to fill orders from the stockpile. Consideration should be given to altering the ORS packets size and to alternative ORS presentations. USAID should also promote the production of quality ORS products within developing countries and continue to support research on other diarrhea intervention strategies. This report also discusses some of the problems involved in manufacturing and packaging ORS. The appendices contain 1) a WHO and UNICEF statement on the ORS formulation made with citrate instead of bicarbonate, 2) a list of developing countries which manufacture ORS, and 3) statistical information on distribution of ORS by international sources.
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  3. 3

    Social marketing: its nature, scope, tasks and relationships.

    El-Ansary AI

    Alexandria, Virginia, Keene, Monk and Associates, 1984 Nov 5. 56 p. (Contract No. PDC-0092-1-02-4045-00)

    This document defines social marketing and delineates its objectives; discusses, in detail, the role of market segmentation and market research in social marketing; describes the concept of mix planning in reference to product design, packaging, pricing, advertising, promotion, and distribution; and identifies the skill requirements of effective social marketers. Social marketing uses the techniques of commerical marketers to increase the acceptability of social ideas, causes or products in a target population. The social marketing process includes 1) market research to identify the needs of the target audience, 2) segmenting the target population, 3) designing offerings to match the needs of the target audience, 4) establishing a price for the offering consistent with the target population's ability to pay, 6) communicating information about the product to the target audience, and 6) making the offering accessible to the target group. Market segmentation refers to the division of a large heterogeneous population into smaller and more homogeneous submarkets or audience groups. Social marketers then select appropriate submarkets as targets of the marketing program and develop alternative and relevant marketing strategies for each selected submarket. For example, specific market programs may be designed for influencers, decision makers, buyers, and users. These submarkets may be further segmented on the basis of geographic, demographic, socioeconomic, psychographic, behavioral, or consumption characteristics. Social marketers seek to promote cognitive, action, behavioral, or value changes in the target audience. In order to effectively promote these changes social marketers must be aware of the variables which influence decision making. Market research is a critical component of social marketing. Market research is used to conduct market consumer, and institutional analyses; to develop market objectives, plans, and strategies; to test and refine marketing plans; and to implement and evaluate marketing programs. A variety of techniques are used in conducting market research. Qualitative techniques are generally used to collect preliminary or exploratory information and include focus groups and indepth interviews. Semiquantitative techniques include panel studies, central location intercept interviews, and field tests. Quantitative information is colleted by surveying large representative sample populations. When consumers buy a product they are purchasing a benefit bundle which includes the product's physical, service, and symbolic attributes. Product acceptability and differentiation from other products is achieved by adopting appropriate design, packaging, promotional, pricing, and distribution strategies. Social marketing is a problem solving, technical, managerial, and behavioral process, and social marketers need a combination of problem solving, technical, behavioral, communication, and management skills to design, develop, and operate successful marketing programs.
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  4. 4

    Caribbean contraceptive social marketing project, a project of the Futures Group: progress report.

    Futures Group

    Washington, D.C., Futures Group, [1984]. [2] p.

    The current status of the Caribbean contraceptive social marketing project, implemented by the Futures Group in conjunction with the Barbados Family Planning Association, is described. Contraceptive social marketing is a strategy in which commercial marketing techniques are used to promote the subsidized sale of contraceptive products. The contraceptives distributed in the Caribbean program are provided by the US Agency for International Development (USAID). Under a contract with USAID, the Futures Group, a private management and marketing consulting firm, provides financial and technical assistance for the Caribbean project. The project represents the 1st attempt to implement a social marketing project on a regional basis. The program is in the initial implementation stage and, at the present time, involves only Barbados, St Lucia, and St Vincent. Later, the program will be extended to Antigua, Dominica, St. Kitts and Nevis, and Trinidad and Tobago. Many of these countries requested their own social marketing program, due in part to their high rate of teenage pregnancy; however, the cost of setting up a separate program in each of these countries would be prohibitive. For this reason the regional approach was adopted. Many elements of an existing social marketing program in Jamaica were transferred to the Caribbean project after a study demonstrated that these elements were culturally acceptable to other countries in the Caribbean region. The Caribbean project distributes Pearl, a standard dose oral contraceptive (OC), Pearl LD, a low dose OC, and Panther, a condom. The USAID-developed package for Panthers was used in the program, and the Pearl package, used in the Jamaican project, was updated for use in the regional program. The regional advertising firm of Corbin, Compton Associates, based in Barbados, was hired to promote the products. The agency developed point of purchase materials and mass media messages, using the successful Jamaican slogan, "if you care about life." Since Caribbean youth rely on their elders for advice, a mature voice is used to present family planning messages over the radio. Panther commercials explain that real men take responsibility for family planning. Frank B. Armstrong, Limited, a firm experienced in distributing pharmaceuticals, was hired to distribute the program's products. In Barbados, the products are currently available in almost all pharmacies, in 1/3 of the country's supermarkets, and 1/2 of the country's small retail outlets. In the other 2 countries, they are available in selected pharmacies and small shops. Prices for the products are set differently in each country and are well below the price of commercially marketed contraceptives. The program was officially launched in February, 1984, by holding receptions for pharmacists and physicians in each of the 3 countries. Numerous meetings will be held in the future to promote the program among community leaders, health providers, and medical associations. The initial reaction to the program was positive in all 3 countries. The program includes a research component. The Operation Research Project of Tulane University, a USAID funded project, will be in charge of the research component. The impact of the advertising campaign will be monitored, and information will be collected periodically to assess the impact of the program on contraceptive usage and purchases. The research protocol is expected to be applicable to other social marketing programs outside the Caribbean region. The Futures Group's resident advisor for the project is Gail A. Washchuck, and the project's director is Enric C. Connolly. In view of the smooth initiation of the project, the launch date for the programs in the remaining countries may be advanced to early 1985.
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  5. 5

    Trip report: Honduras Contraceptive Social Marketing Program, Tegucigalpa, Honduras, June 11 - June 18, 1984.

    Levy T

    Washington, D.C., Futures Group, International Contraceptive Social Marketing Progam, 1984. 25 p. (Project No. AID/DSPE-CA-0087)

    At the request of the International Contraceptive Social Marketing Project, Tennyson Levy of the Tritora Corporation visited Honduras in June, 1984, to assist the Honduras Contraceptive Social Marketing Project to conduct market research to assess the impact of a 5-week advertising program. The campaign was undertaken to launch the introduction of the program's 1st product, Perla, a standard dose oral contraceptive (OC). During the visit the consultant was asked to assist in the development of an advertising plan for all 4 products which will be distributed by the program. The other 3 products are 1) Prebien, a low dose OC; 2) Guardian, a condom; and 3) Sana, a vaginal tablet. The consultant also helped develop research to guide the development of appropriate packages for the Guardian and Sana products. The distribution of Perla began in March, 1984, and the media campaign was conducted during May, 1984. Monthly sales for March amounted to 5271 cycles, and for May, 11,256 cycles. The campaign consisted of 2 45-second radio spots which ran 30 times a day for a month and a press ad. A visit to 12 pharmacies in June to obtain feedback about the advertising campaign led to the conclusion that the campaign increased awareness of Perla, of how it could be obtained, and of how much it cost; however, the campaign did little to alter women's fears and misconceptions about OCs. Recommendations were made for conducting a 2-phase advertising campaign to further promote Perla. The 1st phase will begin immediately and run for 8 weeks. The objective of the 1st phase will be to address women's fears and misconceptions about OCs. The 2nd phase will run from September 1984-July 1985, and the objectives of this phase will be to promote Perla as a method to avoid pregnancies which might keep women from attaining their personal goals, to encourage married women to use Perla to space their births and to limit family size, and to protect unmarried women from the fear of an unwanted pregnancy. Specific messages and channels for disseminating the messages for each phase of the campaign were specified. Communication strategies for the other 3 products were also provided. Guardian messages will seek to equate the macho image with responsible behavior. The Prebien campaign will be directed toward 16-24 year olds, and the Sana compaign will stress that vaginal tablets are a convenient method for lactating women, for teenagers, and for women who engage in sexual activities infrequently. A research strategy for conducting market research throughout the 13-month advertising campaign was developed. A previously developed survey questionnaire for evaluating the advertising campaign was redrafted, and an appropriate sampling strategy for the survey was developed. Pertinent research topics were identified, and a research time table was proposed. An advertising budget was also developed. Funds currently available for the campaign (US$93,000) are inadequate, and additional funds must be requested. The radio spots used in the initial Perla campaign are included in the appendix.
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  6. 6

    Cabbages and condoms: packaging and channels of distribution.

    Potts M

    Clinics in Obstetrics and Gynaecology. 1984 Dec; 11(3):799-809.

    Preventive services, such as family planning, require wider channels of distribution and promotion than curative therapies. The more channels of distribution that are available for a contraceptive method, the higher the prevalence of use. The feedback that retail and social marketing can provide allow systems to be put into place that respond to consumer needs without offending societal traditions. Major innovations in condom promotion has revolved around packaging. It is useful to develop channels of distribution that supply contraceptives both to the user and the partner. To make an old method available through a new channel can be as useful as inventing a new contraceptive method. Often, the community-based distribution of contraceptives is the 1st element in the provision of primary health care. Continuous attention should be given to maximizing channels of contraceptive distribution and seeking numerous alternate ways of approaching the same fundamental goal. At all times, however, the user should be informed of the risks and benefits of a given method.
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  7. 7

    Developments in oral rehydration therapy (ORT).

    Program for Appropriate Technology in Health [PATH]

    In: Infant and child survival technologies, annual technical update No. 1 by Technologies for Primary Health Care Projects [PRITECH]. Arlington, Virginia, Management Sciences for Health, PRITECH Project, 1984 Sep. 15-8.

    WHO and UNICEF have recommended a universal oral rehydration solution (ORS) for the treatment of dehydration caused by diarrhea. Several features of this formula have been debated. Some pediatricians in developed countries have expressed concern about the sodium content of the solution, arguing that this can potentially cause an excess of sodium in the blood. However, when used properly, significant adverse consequences of the high sodium concentration (90 mmol/liter pf the solution) have not been demonstrated, and formulas employing lower sodium concentrations have not proven uniformly adequate in correcting dehydration. The replacement of glucose with sucrose in ORS has also been investigated. In the past few years, futher studies have been undertaken to investigate possible improvements in the ORS formula. For instance, a formula employing sodium citrate in the same molarity as the sodium bicarbonate has been proven effective in field studies sponsored worldwide by WHO. The citrate is now recommended for all packets as it extends shelf life. Other alternatives and supplements to the simple sugar in the formula are also under investigation. Solutions using rice-based starches have been demonstrated to be as effective in correcting dehydration as those using glucose or sucrose. In addition, the caloric intake is twice as high with rice-fortified ORS as with regular ORS. Research is under way to identify a super ORS in which the formula is modified to increase further the absorption of water and sodium from the intestinal lumen. Controversy over the potable quality of water for preparation of ORS continues. There is no evidence that bacterial contamination in any way changes the physiologic effectiveness of the resulting ORS solution. Recent studies show that boiling ORS does not change its compostion. Thus, to ensure the quality of water ORS can be boiled. More attractive ORS market presentations, e.g., ORS in tablet form, the provision of pre-mixed solutions in cheap containers such as those for juices, are being introduced in the commercial sectors of many countries. Uses of oral rehydration are reviewed for neonates, for hypernatremia and hyponatremia and other dehydrating conditions such as respiratory illness and dengue hemorrhagic fever and shock syndrome.
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  8. 8

    General discussion [of factors affecting acceptance and compliance in use of oral contraception].

    Singapore Journal of Obstetrics and Gynaecology. 1984 Mar; 15(1 Suppl):119-23.

    The relative importance of several aspects of oral contraception, i.e., acceptance and compliance, are reviewed. Focuses on reliability, presentation and formulation, cycle control, safety, reversibility, and subjective side effects. Although oral contraceptive (OC) failure may not be such an important event for the population as a whole, it is for the woman who relied on the pills' contraceptive effect. A pill failure in 1 woman may deter many others, who may either stop using OCs or never begin. Data on pill reliability are almost entirely from studies in wrestern nations, and hard data on reliability in the Asian cultural setting may be helpful. The 1st OCs came as 20 tablets in a bottle. Since then different kinds of packaging have been developed, e.g., wheels, bubble strips, differently colored pills for different days. If funds are scarce, however, price-increasing extras will hold little attraction; in such circumstances just 21 tablets in a blister pack will be sufficient. Some types of OCs ensure better cycle control than other. A woman using an OC that does not ensure good cycle control will, at best, ask to be changed to another brand, or she simply will stop taking the pill. The reduced menstrual flow in OC users, which is often claimed in the literature to be an advantage that women appreciate, is often a cause of concern or even discontinuation in Korea. Spotting can be distressing, particularly for Muslim women, but as mutis have now ruled that a woman can still pray when spotting, the negative effect of occasional spotting on motivation will most likely diminish. Doctors may have a good idea of the relative metabolic safety of OC, but field workers, paramedics, and the less well-trained assistants will have a more limited insight. The field workers' influence is a crucial factor. Few of the field workers whose supply OCs and disseminate knowledge actually use OCs themselves. Thus their message will not be very convincing. In the western countries large numbers of teenage girls have been using OCs for some time with no subsequent impairment of fertility. Subjective side effects, such as nausea, may be trivial, but they often discourage women from starting to use OCs or from continuing after the first few months. Subjective side effects are less marked than those experienced with the pills on 15 years ago.
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  9. 9

    The oral contraceptive PPI: its effect on patient knowledge, feelings, and behavior.

    Sands CD; Robinson JD; Orlando JB

    Drug Intelligence and Clinical Pharmacy. 1984 Sep; 18(9):730-5.

    The distribution of the patient package insert (PPI) by pharmacists is at best controversial. Although most health professionals agree that the patient has the right to receive information about drugs, they disagree on the best way to provide that information. Since the oral contraceptive (OC) PPI has been in routine use for approximately 10 years, a large data base exists that can be used to determine not only patient acceptance of the PPI, but also knowledge, feelings, and behavior secondary to the PPI. In this study, 50 women of childbearing age completed a questionnaire, and it was learned that 84% had taken or were currently taking OCs, and 90% of those received a PPI; however, only 61% of these women read all of it. The women performed poorly on the knowledge exam (mean +or- SD, 44.5 +or- 21.2, range 0-83%); those who read all of the PPI or who were white had higher scores (P0.02 and P0.001). 38% of the women thought that the PPI information was inadeqaute, suggesting that it needs to be rewritten and/or supplemented with information from pharmacists. After reading the PPI, 12% contacted their pharmacist for additional information. Pharmacists are in a unique position to provide OC information that enables women to make informed judgments regarding benefit: risk ratios on a personal basis. (author's)
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  10. 10

    A historical overview of the implementation of oral contraception in Singapore.

    Pakshong DI

    Singapore Journal of Obstetrics and Gynaecology. 1984 Mar; 15(1 Suppl):109-13.

    In 1966, Singapore's governemnt family planning clinics made available 8 different oral contraceptive (OC) formulations. Over the years, the range of pills offered has changed in accordance with decisions by the Medical Committee. Currently, OCs are available from all 29 maternal and child health centers as well as the National Family Planning Center. These centers are strategically located throughout the island and are easily accessible. Originally, the price of a monthly cycle of pills was S$1.50, but this was reduced to S$1.00 in 1968, however, contraceptives are given free to any person who is unable to pay. The Singapore Family Planning and Population Board has deliberately retained the commercial packaging of the OCs offered in its clinics, lest clients fear that pills offered at such nominal charges are in some way inferior or different from those obtainable from the private sector at higher cost. Following the policy of reorientation in mid-1966, the pill replaced the IUD as the main contraceptive method. By the end of the year, out of 30,440 new acceptors, 46% had chosen OCs, 27% the condom, and 9% the IUD. The popularity of both OCs and the condom continued to rise steadily. In 1974 OCs were chosen by 58% of 18.292 new acceptors and the condom by 40%. Over the next 2 years the gap between OC and condom choice narrowed, and in 1977 the pill was overtaken by the condom. OC acceptance has continued to decline despite intensified motivational and educational approaches through group talks, individual counseling, and a special pamphlet answering some commonly voice fears about OCs. In 1982 the condom was chosen by 64% of new acceptors and OCs by 33%. The fall in the popularity of the pill in recent years has occurred in the wake of periodic press reports from the West about increased risks among older OC users of venous thromboembolism, ischemic heart disease, and cerebrovascular disease, especially among smokers. Despite the decline in acceptance of OCs in favor of condom, there has been an impressive drop in the crude birthrate from 28.3 in 1966 to 17.3 in 1982 and in the total fertility rate from 4.456 to 1.704 over the same period.
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  11. 11

    Expert meeting on oral contraceptive needs of developing countries.

    Briere R

    [Unpublished] 1984. i, 17 p.

    On March 8, 1984, a group of experts was assembled by the American Public Health Association (APHA) to discuss oral contraceptive (OC) needs of developing countries. The group reviewed current information on OC clinical trial performance, lipid effects, potency/dosage issues, relationship to female reproductive cancers, specific developing country concerns, and various programmatic issues. Particular concern was voiced about the need to try to avoid OC formulation switching in developing country programs since this can have significant adverse effects. Because of logistical difficulties, many developing country programs have difficulty suppling more than 1 OC. Recommendations for minimizing this continuity problem include: 1) providing a single predominant OC for most developing country programs; 2) engaging in multiple-year procurements; and 3) attempting to continue to provide a particular formulation in special circumstances where it has a high proprietary and/or continuity value, (e.g., social marketing programs). Some 30-35 ug estrogen OCs currently available in the US appear to perform in clinical trials at roughly the same general acceptable level as the 50 ug estrogen OCs. Accordingly, there was a general consensus among the group that a single predominant pill should be selected from among these particular 30-35 ug estrogen OCs. At the same time, it was clearly not the group's intent to recommend limiting OCs provided to developing countries to this particular set. Based on concern about human variability, contraceptive efficacy, program continuity, and the desires of developing countries themselves, another list of formulations was also considered suitable. (author's modified)
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  12. 12

    Where the tom-tom beats.

    Brudon-Jakobovicz P

    World Health. 1984 Jul; 20-1.

    Cultural and sociological factors frequently hinder the acceptance and proper use of drugs among rural villagers in developing countries. These constraints must be recognized by the modern health community if efforts to make affordable drugs available in the context of primary health care (PHC) programs are to meet with success. In many countries, villagers have more confidence in their traditional curative system than in the modern medical system. The traditional system is embedded into and supported by villagers' culturally defined reality while modern medical practices, e.g., vaccinations and mosquito eradication programs, appear to be a series of bizarre behavioral acts having no culturally conceptualizable purpose. Traditional definitions of "being ill" may also differ from modern definitions of "being ill." In Indonesia, 45% of the people surveyed said that a person is ill only when that person cannot get up or is unable to work. If one is not ill, of course, there is no need to take medicine. Other cultural and social factors may interfere with the proper use of drugs. Sometimes drugs become status symbols, and drug taking becomes a way of identifying with the modern social system. Consequently villages often demand the most expensive drugs, in the fanciest packages, in the mistaken belief that these drugs are more effective than less expensive drugs. In Mali, for example, there is a strong preference for using injectable quinine salts to counter malaria rather than the less expensive, safer, and more effective chloroquine pills. The importance of these cultural constraints on the acceptance and proper use of drugs must be recognized by modern health personnel, and especially by village worker . Communication between the health worker and the villagers must be improved and efforts made to increase the villagers' confidence in the health care provided by local health centers. One way to increase the confidence level is to package drugs, distributed by the health centers, in such a way as to remove any suspicion that the drugs are a second rate product. The drugs should be presented in attractive packages, and directions for taking the pills should be clearly stated and carefully illustrated. Efforts should also be made to improve the villagers' understanding of why the drugs are being prescribed.
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  13. 13
    Peer Reviewed

    The role of epidemiology in the regulation of oral contraceptives.

    Sobel S

    Public Health Reports. 1984 Jul-Aug; 99(4):350-4.

    The US Food and Drug Administration (FDA) has relied to a great degree on epidemiologic studies in the regulation of oral contraceptives (OCs). These epidemiologic studies range from individual case reports of adverse reactions to case control studies and cohort studies. Important findings about adverse reactions to OCs have been communicated through labeling, which includes information leaflets provided as package inserts for physicians and patients. Also, the FDA communicates its position through publications in medical journals, the FDA Drug Bulletin, public advisory committee meetings, workshops, and symposia. The agency responds to new epidemiologic information. Labeling guidelines are under continuing review and revision. Patterns of OC use have been affected by the dissemination of this information. There has been adecline in the use of OCs, a shift to formulations with lower steroid content, and a greater emphasis on OC use inoptimal groups, such as young, nonsmoking women. Considered for future epidemiologic studies that may have an impact on regulatory action are a clarification of the role of various progestins in regard to blood lipid alteration and atherogenesis, a delineation of the possible persistence of cardiovascular risk after termination of OC use, and further claraification with regard to neoplasia, particularly breast and cervical carcinoma. (author's modified)
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  14. 14

    All contraceptives have problems: toxic-shock syndrome and the vaginal contraceptive sponge.

    Faich GA; Sobel S; Bilstad J

    North Carolina Medical Journal. 1984 Mar; 45(3):197-8.

    In lat 1984, 4 reported cases of toxic shock syndrome (TSS) meeting Centers for Disease Control (CDC) criteria occurred among users of the vaginal contraceptive sponge (Today). All patients manifested fever, hypotension, diffuse rash, desquamation, nausea, vomiting, myalgias, mucous membrane hyperemia, and vaginal discharge. All were hospitalized and treated with intravenous fluids and antimicrobial agents, and all recovered. Vaginal cultures in every case were positive for Staphylococcus aureus. The Today Vaginal Contraceptive Sponge, introduced to the over the counter market in June 1983, is made of polyurethane impregrated with the spermicide nonoxynol-9 and is intended to provide 24 hours of contraception. During clinical trails, the average woman using only this contraceptive method used 10 sponges per month. At the time the sponge was licensed, the US Food and Drug Administration (FDA) required that the package insert contain a warning that clinical trials had not been large enough to assess the risk of TSS and that users should seek medical care if symtoms compatible with TSS developed. Instructions for sponge use indicate that it should not be left in place for more than 30 hours. Following a meeting with FDA representatives on December 16, the manufacturer highlighted the warning on the package insert and placed a similar warning on the outer box. Women who use contraceptive sponges should read the package insert carefully and follow the manufacturer's directions. Users who experience difficulty removing a sponge and/or fragmentation should consult a physician. Women who have had TSS, particularly if it was associated with the use of a contraceptive sponge or tampon, should also consult a physician before beginning or resuming use of either. Postpartum women, who may be at an increased risk of developing TSS, should seek medical advice before using the contraceptive sponge. This report of 4 TSS cases among women using the contraceptive sponge is presented to inform physicians that a potential problem may exist and to encourage the reporting of additional cases. If one assumes that the 4 cases reported thus far were all attributable to contraceptive sponges, a minimum estimate of the incidence of nonmenstrual TSS associated with sponge use would be 10 cases/year/100,000 women who use contraceptive sponges as their only contraceptive method.
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  15. 15

    Ortho markets first FDA-approved triphasic pill.

    Contraceptive Technology Update. 1984 Jun; 5(6):69-71.

    Ortho-Novum 7/7/7, the 1st triphasic oral contraceptive to be approved by the FDA (Federal Food and Drug Administration) is now being marketed in the US by the Ortho Pharmaceutical Corporation. The triphasic pill is similar to the biphasic pill as the steriod level is varied during the cycle, but the new triphasic pill more closely follows the normal ovulatory cycle cycle in regard to steriod levels. During days 1-7 of the cycle, the dosage is 0.5 mg of progestogen and 35 mcg of estrogen. Respective doses for days 8-14 are 0.75 mg amd 35 mcg and for days 15-21 they are 1.0 mg and 35 mcg. The total dosage of progestogen for the entire cycle is 15.75 mg. The new pill is associated with less breakthrough bleeding than the biphasic pill and the bleeding pattern is similar to that observed for Ortho 1-35. 2 pregnancies were observed during worldwide clinical trails but only 1 was attributed to product failure. The Pearl Formula failure rate was 0.22 or less. The incidence of side effects was low. The pill is packaged in a 28-day circular dial pack which contains 7 white, 7 light peach, and 7 dark peach pills with an additional 7 placebo pills. Some objectives have been raised concerning the packaging of the product. The pills are very similar in color and patients might find this confusing. Ortho representatives indicated that this should not be a problem if patient are given sufficient counseling.
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  16. 16

    Recognizing DMPA as a contraceptive [letter]

    Britton TF

    American Journal of Nursing. 1984 Mar; 84(3):306.

    There is an error in "The Pill, A Closer Look" (October) that I believe deserves comment. Depo-Provera (DMPA) is an approved drug in the US and is available nonexperimentally for contraception. The discrepancy is a common mistake in interpreting FDA's current listing or "approved labeling" as the only way a given drug may be used in regular clinical practice. DMPA has approval for marketing in the US, and while its current approved labeling does not include contraception, it is well recognized as a contraceptive agent and is very definitely available outside the research establishment for this purpose in legitimate practice. The only limitation on its use for this purpose is the policy of individual clinics or practitioners. The article strongly implies that it is currently illegal or unethical practice in the US for a clinician to use this drug as a contraceptive in routine practice. That is untrue, and private OB-Gyn offices in our community are good examples. (full text)
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  17. 17

    Maker of contraceptive sponge responds to toxic shock reports.

    Medical World News. 1984 Mar 12; 25(5):26, 31.

    4 confirmed cases of toxic shock syndrome (TSS) associated with use of the Today vaginal contraceptives were reported in the Centers for Disease Control's (CDC) "Morbidity and Mortality Weekly Report." The 4 women involved in the cases, occurring between October 16 and December 10, 1983, were hospitalized but responded to intravenous fluids and antimicrobials and recovered. Gail Bolan, CDC medical epidemiologist, reports that her agency has received no reports of confirmed cases of TSS associated with the sponge's use since December. CDC officials await follow-up information on several suspected cases. Bolan emphasizes that the published report is not intended to imply that a risk of TSS has been established for sponge users. The numbers are too small to make an accurate estimate of any risk of toxic shock for women using the sponge. The point of the article is to make people aware of these developments and to encourage reporting of additional cases so risk can be determined. In giving VLI Corporation of Irvine, California approval to market the contraceptive, US Food and Drug Administraion (FDA) officials noted that clinical trials were not sufficiently large to assess the risk of TSS. Laboratory tests indicate the sponge does not support growth of Staphylococcus aureus, the suspected etiologic culprit in TSS. The 4 confirmed cases prompted a meeting between FDA officials and representatives of VDL. After the meeting, company officials voluntarily agreed to highlight TSS warnings already included on the package insert and to alert users to TSS by adding the warnings to the outside of the package, according to company representative Debra Gaynor. The insert warnings urge users to seek medical attention immediately if they have 2 or more symptoms of TSS; to remove the sponge within the specified time (24-30 hours) and call the company on a toll free line or seek a physician's assistance if difficulty arises when removing the device; and to consult a physician or clinic before using the product after childbirth, miscarriage, or other pregnancy termination. VLI acknowledges receiving more than 100 reports of difficulty in removing the contraceptive. As a result, the company has revised the package to include more specific information. Dr. Armand Lione, president of Associated Pharmacologists and Toxicologists, and an early critic of the sponge has adopted a wait and see attitude toward the TSS developments. The Washington based research group petitioned the FDA last summer to reassess its approval of the contraceptive, contending the device was not adequately tested to determine the risk of exposure to dioxane. FDA officials are delaying a response to the petition for reassessment until they have made a final review of the TSS information.
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  18. 18

    TSS reported in 4 users of contraceptive sponge.

    Ob Gyn News. 1984 Mar 15-31; 19(6):3.

    4 cases of toxic shock syndrome (TSS) were reported late last year among users of the new Today vaginal contraceptive sponge, according to the Centers for Disease Control. Although it has not been conclusively determined that TSS is associated with contraceptive sponge use, physicians should be aware "that a potential problem may exist," the CDC says. Bruce Vorhauer, Ph.D., founder and president of the device's manufacturer, VLI Corporation, Irvine, California, said the CDC report indicates that the contraceptive sponge was used improperly in at least 3 of the cases. In 1 case, a California woman left the contraceptive sponge in place for 32 hours and had difficulty removing it; another California woman left the sponge in place for 5 days. According to instructions included with the sponge, it should not be left in place for longer than 30 hours, Dr. Vorhauer said in a telephone interview with this newspaper. In another case, a Georgia woman used the sponge for the 1st time 37 days postpartum. The company had recommended that postpartal women, who may be at an increased risk of developing TSS, should seek a physician's advice before using the contraceptive sponge. In the 4th case, an Oregon woman reported TSS symptoms following tearing of the sponge during several unsuccessful attempts to remove it, the investigator said. All of the women had fever, hypotension, diffuse rash, desquamation, nausea, vomiting, myalgias, mucus-membrane hyperemia, and vaginal discharge, according to the CDC report. Vaginal culture in each case revealed Staphylococcus aureus, a bacterium believed to be responsible for TSS. None of the women were menstruating at the reported onset of the symptoms. Each of the patients was hospitalized and treated with intravenous fluids and antimicrobial agents. All of the women recovered. Although VLI is seeking to determine whether the illnesses reported to the CDC were in fact TSS, it has agreed to highlight the warning about TSS on the sponge's package insert and place a similar warning on the outer wrapper of the product (Ob. Gyn. News, Jan. 15, 1984, p.43). Since early 1984, more than 8 million of the contraceptive sponges have been distributed nationwide, and there are more than 400,000 users, he pointed out. The sponges are expected to be available in every state soon, Dr. Vorhauer said. (full text)
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  19. 19

    Questions and answers of the Fertility and Maternal Health Drugs Advisory Committee.

    Gregoire AT; Sobel S; Weiner A; Bennett R; Bilstad J; McCann D; Carter L; Price P; Lamar J; Millstein L

    [Unpublished] 1984 Feb. 4 p.

    A recent publication in "Lancet" by Pike et al. concluded that women who used oral contraceptives (OCs) for extended periods of time before age 25 were at an increased risk for the development of breast carcinoma. The authors also suggested that OCs with high progestational activity, as determined by a delay of menses test, accounted for this elevated risk. Other studies have addressed the issue of the relationship of OCs and breast carcinoma and the findings have been presented to the Fertility and Maternal Health Drugs Advisory Committee. The Committee, after a careful review of the paper by Pike et al. and a number of other recent studies relevant to OC use and breast cancer, concludes that a significant increase in risk for development of breast cancer has not been demonstrated in any subgroup of OC users or with any particular OC. The Agency is increasingly concerned about several studies which have shown an increased incidence of cervical carcinoma in patients using OCs. Probably a major problem in interpreting the results of these studies is the inability to eliminate with certainty the possible confounding effects of sexual activity. The Committee believes the changes suggested in the labeling reviewed 2 years ago under the heading "carcinoma" will answer the question regarding cervical cancer and no other changes need to be considered. The Agency has favored the use of OCs with lower steroidal content. In regard to the estrogen component, a clear recommendation has been made for the use of the low estrogenic dose. At this time there is no specific recommendation in regard to progestin content. This is due in part to an uncertainty of the ranking of progestational potencies of the various progestins. There is a less clear association of progestin with cardiovascular events. Recently, there is increased concern about the possible contribution of the progestin content to cardiovascular morbidity and mortality. This contribution may be mediated by effects on blood pressure, lipids, and perhaps blood clotting. The statement in the proposed changes in the current labeling under "Dose related risk of vascular disease from oral contraceptives" is believed to answer the question regarding risk and labeling. There are possible additional risks that may be associated with the inclusion of progestational agents in the estrogen replacement regimen. The potential risks include adverse effects on carbohydrate and lipid metabolism and possibly on coagulation factors. The Committee does not feel that labeling for progestin in estrogen replacement therapy is necessary at this time because of uncertainty about their safety.
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  20. 20

    Advisory committee finds breast cancer-OC link unconvincing.

    Cruzan SM

    Rockville, Maryland, Food and Drug Administration, 1984 Feb 13. 2 p. (FDA Talk Paper T84-15)

    FDA's Fertility and Maternal Health Drugs Advisory Committee met February 9 and 10 to review data concerning the possible relationship of oral contraceptives (OCs) and breast and cervical cancer. Dr. Malcolm Pike, senior author of a study recently published in the Lancet presented his views before the committee. His study linked an increased risk of breast cancer with the use of "high progestogen" OCs for an extended period before the age of 25. The committee said, "After careful review of the paper by Pike et al., plus a number of other studies relevant to OC use and breast cancer, the committee concludes that a significant increase in the risk or development of breast cancer has not been demonstrated for any subgroup of OC users." The committee referred to a larger study by the Centers for Disease Control, which presented a reanalysis of its data, as well as smaller studies that have not shown a significant association between the use of OCs and breast cancer. Nevertheless, the committee recommended that the labeling for OCs should advise annual breast exams along with annual Pap tests. Another paper published in the same issue of the Lancet reported an increased risk of cervical cancer. The committee said it is difficult to interpret the study because the history of sexual experience in the study subjects is not known. The committee stated that labeling revisions which have been suggested previously by the advisory committee and which are now under review by FDA address that risk. The revised labeling states that OC use may be associated with an increase in the risk of developing intraepithelial cervical neoplasia (a precancerous condition) but differences in sexual exposure between users and the nonuser may account for the difference in risk. The committee also addressed the issue of the progestin content of OCs because of the possible adverse effects of this component on the cardiovascular system. The committee again referred to labeling revisions already under review which recommend that doctors prescribe OCs with the least amount of progestin along with the least amount of estrogen compatible with the needs of patients. FDA will review the committee's recommendations before deciding what action it will take. (full text)
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